EyeGate Pharma Enrolls First Patient in Confirmatory Phase 3 Clinical Trial EGP-437-006 for Non-Infectious Anterior Uveitis
Data Anticipated Q1 2017
WALTHAM, Mass., Jan. 19, 2016 (GLOBE NEWSWIRE) -- Eyegate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the “Company”), a specialty pharmaceutical company that focuses on developing and commercializing therapeutics and drug delivery systems for treating diseases of the eye, today announced that the first patient was enrolled in the Company’s confirmatory Phase 3 clinical trial of its EGP-437 combination product, the Company’s lead product, in patients with non-infectious anterior uveitis, an inflammation of the anterior chamber of the eye.
“Enrolling the first patient in our second Phase 3 trial for anterior uveitis marks an important milestone for the company as we move another step closer to bringing our EGP-437 combination product to the market," said Stephen From, President and CEO of EyeGate. "I believe that our proprietary iontophoretic formulation of dexamethasone phosphate has great potential in the treatment of anterior uveitis and a variety of other indications which we are currently exploring. The iontophoretic delivery of drug to the eye through our EyeGate® II Delivery System presents a more convenient, potentially more efficacious alternative to topical eye drops and a less painful alternative to intra-ocular injections. We continue to be excited about the potential of our EGP-437 combination product to treat inflammatory diseases of the eye and look forward to its further clinical assessment.”
C. Stephen Foster M.D., of Massachusetts Eye Research and Surgery Institution (MERSI) and the Ocular Immunology and Uveitis Foundation and the first enrolling investigator of the trial added, “Uveitis is one of the leading causes of preventable blindness in developed counties, with anterior segment uveitis accounting for 60-90% of reported cases. Current treatments, which include topical steroids to alleviate symptoms and control inflammation, may present compliance and self-administration challenges, which can potentially be overcome with EGP-437 delivered via iontophoresis.”
The Phase 3 trial is a double-masked, randomized, positive-controlled trial being conducted at up to 60 clinical sites in the United States. The trial intends to enroll up to 250 subjects and is designed to evaluate the safety and efficacy of iontophoretically-delivered EGP-437, a novel formulation of dexamethasone phosphate ophthalmic solution, through the Company’s EyeGate® II Delivery System, in patients with unilateral or bilateral non-infectious anterior segment uveitis. Subjects will receive three treatments of either EGP-437 iontophoresis treatment or a placebo iontophoresis treatment. Patients in the EGP-437 arm will receive placebo eye drops, while patients receiving placebo iontophoresis treatment will be given prednisolone acetate (1%) drops. Eye drops for both arms will be administered for up to 28 days and for up to 8 drops per day. The primary efficacy endpoint is the proportion of subjects with an anterior chamber (AC) cell count of zero at day 14.
About EyeGate:
EyeGate is a clinical-stage specialty pharmaceutical company that is focused on developing and commercializing therapeutics and drug delivery systems for treating diseases of the eye. EGP-437, the Company’s first and only product in clinical trials, incorporates a reformulated topically active corticosteroid, Dexamethasone Phosphate that is delivered into the ocular tissues through EyeGate’s proprietary innovative drug delivery system, the EyeGate(R) II Delivery System. For more information, please visit www.EyeGatePharma.com.
Safe Harbor Statement:
Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements include statements relating to, among other things, the commercialization efforts and other regulatory or marketing approval efforts pertaining to EyeGate’s products, including its EGP-437 combination product, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, certain risk factors described under the heading “Risk Factors” contained in our Annual Report on Form 10-K filed with the SEC on March 31, 2015, or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. EyeGate expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.
Contact: Lee Roth / Joseph Green The Ruth Group for Eyegate Pharmaceuticals 646-536-7012 / 7013 lroth@theruthgroup.com / jgreen@theruthgroup.com
Released January 19, 2016